MAUDE Adverse Event Report: ARTHREX, INC. IBAL UKA, FEMORAL PEG DRILL, DIA. 260; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number IBAL UKA, FEMORAL PEG DRILL, DIA. 260

Device Problem Flaked (1246)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, it was reported by a sales representative via sems that an ar-611-11 femoral peg drill was creating flaky metal.This was discovered during a uka sportsplasty procedure.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Manufacturer Narrative

Complaint confirmed, heavy circumferential abrasion marks were observed on the flute od.A likely cause of the damage is prying/leveraging the device against a guide or another instrument during use.

• Brand Name: IBAL UKA, FEMORAL PEG DRILL, DIA. 260
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13529242
• MDR Text Key: 288633053
• Report Number: 1220246-2022-04476
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867223905
• UDI-Public: 00888867223905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IBAL UKA, FEMORAL PEG DRILL, DIA. 260
• Device Catalogue Number: AR-611-11
• Device Lot Number: 021729
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1